On Friday, the Centers for Medicare & Medicaid Services (CMS) announced tight facilities access restrictions and other critical additional new measures designed to keep America’s nursing home residents safe from the 2019 Novel Coronavirus (COVID-19) in connection with the broader Trump Administration declaration of a national emergency to deal with the COVID-19 outbreak. The guidance follows news that the Washington nursing home with the biggest cluster of COVID-19 deaths to date in the U.S. thought it was facing an influenza outbreak.
The President’s declaration empowers the Secretary of Health and Human Services (HHS) to authorize CMS to take proactive steps through 1135 waivers. Under these emergency procedures, the HHS Secretary is authorized to waive certain Medicare, Medicaid and Children’s Health Insurance Program (CHIP) program requirements and conditions of participation under Section 1135 of the Social Security Act once the President declares an emergency through the Stafford Act or National Emergency Act, and the Secretary declares a Public Health Emergency (PHE). HHS Secretary Alex M. Azar issued a PHE on January 31, 2020. As a result of this authority, CMS has enacted blanket waivers easing certain requirements for impacted providers and states and other relief.
Nursing Home Containment Guidance
Under the Memo Nursing Home Guidance QSO-20-14 –NH issued Friday, HHS directed nursing homes to significantly restrict visitors and nonessential personnel, as well as restrict communal activities inside nursing homes. Specifically, the Memo directs that:
General Restrictions On Access. Facilities should restrict visitation of all visitors and non-essential health care personnel, except for the following:
- Health care workers: Facilities should follow CDC guidelines for restricting access to health care workers found here. This also applies to other health care workers, such as hospice workers, EMS personnel, or dialysis technicians, that provide care to residents. They should be permitted to come into the facility if they meet the CDC guidelines for health care workers. The Memo also states that facilities should contact their local health department for questions, and frequently review the CDC website dedicated to COVID-19 for health care professionals
- Surveyors: CMS and state survey agencies are constantly evaluating their surveyors to ensure they don’t pose a transmission risk when entering a facility. For example, surveyors may have been in a facility with COVID-19 cases in the previous 14 days, but because they were wearing PPE effectively per CDC guidelines, they pose a low risk to transmission in the next facility and must be allowed to enter. However, there are circumstances under which surveyors should still not enter, such as if they have a fever.
- Certain Compassionate Care Visits. The Memo says facilities may allow certain compassionate care situations, such as an end-of-life situations, under certain circumstances discussed below. Facilities are expected to notify potential visitors to defer visitation until further notice (through signage, calls, letters, etc.).
- Ombudsman Program Visits. Residents still have the right to access the Ombudsman program, but the Memo says that access should be restricted per the guidance above (except in compassionate care situations). The Memo states facilities may review this on a case by case basis. If in-person access is not available due to infection control concerns, facilities need to facilitate resident communication (by phone or other format) with the Ombudsman program or any other entity listed in 42 CFR § 483.10(f)(4)(i).
Compassionate Care Access. The Memo directs that facilities make decisions about visitation during an end of life situation on a case by case basis, which includes careful screening of the visitor (including clergy, bereavement counselors, etc.) for fever or respiratory symptoms. Those with symptoms of a respiratory infection (fever, cough, shortness of breath, or sore throat) should not be permitted to enter the facility at any time (even in end-of-life situations).
For individuals that enter in compassionate situations (e.g., end-of-life care), the Memo requires that facilities enforce protective restrictions on access including:
- Facilities should require visitors to perform hand hygiene and use Personal Protective Equipment (PPE), such as facemasks while in the building;
- Visitors must restrict their visit to the resident’s room or other location designated by the facility; and
- Facilities should remind visitors frequently perform hand hygiene.
Safeguards When Visits Allowed. When visitation is necessary or allowable (e.g., in end-of-life scenarios), facilities should make efforts to allow for safe visitation for residents and loved ones such as:
- Suggesting refraining from physical contact with residents and others while in the facility. For example, practice social distances with no hand-shaking or hugging and remaining six feet apart.
- If possible (e.g., pending design of building), creating dedicated visiting areas (e.g., “clean rooms”), near the entrance to the facility where residents can meet with visitors in a sanitized environment.
- Facilities should disinfect rooms after each resident-visitor meeting.
Offer Options In Lieu Of Visits. CMS notes in the Memo that while visitor restrictions may be difficult for residents and families, CMS says the restrictions based on the newest recommendations from the Centers for Disease Control and Prevention (CDC) are an important temporary measure for their protection. In lieu of and to mitigate the effect of visitor restrictions on patients and their families, CMS encourages facilities to consider taking the following steps:
- Offering alternative means of communication for people who would otherwise visit, such as virtual communications (phone, video-communication, etc.).
- Creating/increasing listserv communication to update families, such as advising to not visit.
- Assigning staff as primary contact to families for inbound calls and conduct regular outbound calls to keep families up to date.
- Offering a phone line with a voice recording updated at set times (e.g., daily) with the facility’s general operating status, such as when it is safe to resume visits.
Tighter State Law Restrictions. The Memo states that if a state implements actions that exceed CMS requirements, such as a ban on all visitation through a governor’s executive order, a facility would not be out of compliance with CMS’ requirements. In this case, CMS surveyors would still enter the facility, but not cite for noncompliance with visitation requirements.
When To Consider Transferring Patients With Confirmed COVID-19 Infection To A Hospital. Concerning when to transfer patients with COVID-19 investions to the hospital, the Memo states that nursing homes with residents suspected of having COVID-19 infection should contact their local health department. Residents infected with COVID-19 may vary in severity from lack of symptoms to mild or severe symptoms or fatality. Initially, symptoms may be mild and may not require transfer to a hospital as long as the facility can follow the infection prevention and control practices recommended by CDC. Facilities without an airborne infection isolation room (AIIR) are not required to transfer the resident assuming:
- The resident does not require a higher level of care; and
- The facility can adhere to the rest of the infection prevention and
control practices recommended for caring for a resident with COVID-19.
When Should A Nursing Home Accept Resident Diagnosed With COVID-19 From A Hospital? CMS also notes that nursing homes should admit any individuals that they would normally admit to their facility, including individuals from hospitals where a case of COVID-19 was/is present provided they can provide appropriate precautionary safeguards. The Memo states a nursing home can accept a resident diagnosed with COVID-19 and still under Transmission Based Precautions for COVID-19 as long as the facility can follow CDC guidance for Transmission-Based Precautions. If a nursing home cannot, it must wait until these precautions are discontinued. Also, if possible, Nursing Homes also should dedicate a unit/wing exclusively for any residents coming or returning from the hospital. This can serve as a step-down unit where they remain for 14 days with no symptoms (instead of integrating as usual on short-term rehab floor, or returning to long-stay original room).
CDC has released Interim Guidance for Discontinuing Transmission-Based Precautions or In-Home Isolation for Persons with Laboratory-confirmed COVID-19. As information on the duration of infectivity is limited, the interim guidance was developed with available information from similar coronaviruses. CDC states that decisions to discontinue Transmission-based Precautions in hospitals will be made on a case-by-case basis in consultation with clinicians, infection prevention and control specialists, and public health officials based on multiple factors (see current CDC guidance for further details).
Other Internal Operations To Control Infection. The Memo also indicates that nursing homes should take the following other actions to control exposure within facilities.
- Cancel communal dining and all group activities, such as internal and external group activities.
- Implement active screening of residents and staff for fever and respiratory symptoms.
- Remind residents to practice social distancing and perform frequent hand hygiene.
- Screen all staff at the beginning of their shift for fever and respiratory symptoms. Actively take their temperature and document absence of shortness of breath, new or change in cough, and sore throat. If they are ill, have them put on a facemask and self-isolate at home.
- For individuals allowed in the facility (e.g., in end-of-life situations), provide instruction, before visitors enter the facility and residents’ rooms, provide instruction on hand hygiene, limiting surfaces touched, and use of PPE according to current facility policy while in the resident’s room. Individuals with fevers, other symptoms of COVID-19, or unable to demonstrate proper use of infection control techniques should be restricted from entry.
- Facilities should communicate through multiple means to inform individuals and nonessential health care personnel of the visitation restrictions, such as through signage at entrances/exits, letters, emails, phone calls, and recorded messages for receiving calls.
- Facilities should identify staff that work at multiple facilities (e.g., agency staff, regional or corporate staff, etc.) and actively screen and restrict them appropriately to ensure they do not place individuals in the facility at risk for COVID-19.
- Facilities should review and revise how they interact vendors and receiving supplies, agency staff, EMS personnel and equipment, transportation providers (e.g., when taking residents to offsite appointments, etc.), and other non-health care providers (e.g., food delivery, etc.), and take necessary actions to prevent any potential transmission. For example, do not have supply vendors transport supplies inside the facility. Have them dropped off at a dedicated location (e.g., loading dock). Facilities can allow entry of these visitors if needed, as long as they are following the appropriate CDC guidelines for Transmission-Based Precautions.
The Memo also encourages all nursing homes:
- To monitor residents and others for potential symptoms of respiratory infection as needed throughout the day;
- Advise visitors, and any individuals who entered the facility (e.g., hospice staff), to monitor for signs and symptoms of respiratory infection for at least 14 days after exiting the facility. If symptoms occur, advise them to self-isolate at home, contact their healthcare provider, and immediately notify the facility of the date they were in the facility, the individuals they were in contact with, and the locations within the facility they visited. Facilities should immediately screen the individuals of reported contact, and take all necessary actions based on findings;
- To take advantage of resources that have been made available by CDC and CMS to train and prepare staff to improve infection control and prevention practices;
- To maintain a person-centered approach to care including communicating effectively with residents, resident representatives and/or their family, and understanding their individual needs and goals of care;
- Facilities experiencing an increased number of respiratory illnesses (regardless of suspected etiology) among patients/residents or healthcare personnel to immediately contact their local or state health department for further guidance; and
- To monitor the CDC Resources for Health Care Facilities for information and resources and contact their local health department when needed.
Exposure To Citation For Inadequate Supplies During COVID-19 Crisis. The Memo states that as CMS is aware of that there is a scarcity of some supplies in certain areas of the country, State and Federal surveyors should not cite facilities for not having certain supplies (e.g., PPE such as gowns, N95 respirators, surgical masks and ABHR) if they are having difficulty obtaining these supplies for reasons outside of their control. However, the Memo also states that CMS expects expect facilities to take actions to mitigate any resource shortages and show they are taking all appropriate steps to obtain the necessary supplies as soon as possible. For example:
- If there is a shortage of ABHR, we expect staff to practice effective hand washing with soap and water. Similarly, if there is a shortage of PPE (e.g., due to supplier(s) shortage which may be a regional or national issue), the facility should contact the local and state public health agency to notify them of the shortage, follow national guidelines for optimizing their current supply, or identify the next best option to care for residents.
- If a surveyor believes a facility should be cited for not having or providing the necessary supplies, the state agency should contact the CMS Branch Office.
Facilities also will want to ensure their documented compliance with the following additional direction to facilities:
- Review CDC guidance for Infection Prevention and Control Recommendations for Patients with Confirmed Coronavirus Disease 2019;
- Increase the availability and accessibility of alcohol-based hand rubs (ABHRs), reinforce strong hand-hygiene practices, tissues, no touch receptacles for disposal, and facemasks at healthcare facility entrances, waiting rooms, resident check-ins, etc.
- Ensure ABHR is accessible in all resident-care areas including inside and outside resident rooms.
- Increase signage for vigilant infection prevention, such as hand hygiene and cough etiquette.
- Properly clean, disinfect and limit sharing of medical equipment between residents and areas of the facility.
- Provide additional work supplies to avoid sharing (e.g., pens, pads) and disinfect workplace areas (nurse’s stations, phones, internal radios, etc.).
- Take full documented advantage of other available resources for facilities to help improve infection control and prevention including:
- Infection preventionist training:
- CDC Resources for Health Care Facilities;
- CDC Updates;
- CDC FAQ for COVID-19;
- Information on affected US locations;
- Guidance for use of Certain Industrial Respirators by Health Care Personnel;
- Long Term Care Facility – Infection Control Self-Assessment Worksheet;
- Infection Control Toolkit For Bedside Licensed Nurses And Nurse Aides (“Head to Toe Infection Prevention (H2T) Toolkit”);
- Infection Control And Prevention Regulations And Guidance: 42 CFR 483.80, Appendix PP of the State Operations Manual. See F-tag 880.
Other COVID-19 Relief For Health Care Providers and States
As part of its exercise of its section 1135 waiver authority, CMS also now is encouraging states and territories are now encouraged to assess their needs and request these available flexibilities, which are outlined in the Medicaid and CHIP Disaster Response Toolkit. Examples of flexibilities available to states under section 1135 waivers include the ability to permit out-of-state providers to render services, temporarily suspend certain provider enrollment and revalidation requirements to promote access to care, allow providers to provide care in alternative settings, waive prior authorization requirements, and temporarily suspend certain pre-admission and annual screenings for nursing home residents.
Waivers and Flexibilities for Hospitals and other Healthcare Facilities. CMS has and is temporarily waiving or modifying or modify certain Medicare, Medicaid, and CHIP requirements. CMS will also issue several blanket waivers, listed on the website below, and the CMS Regional Offices will review other provider-specific requests. These waivers provide continued access to care for beneficiaries. For more information on the waivers CMS has granted, see here.
Provider Enrollment Flexibilities. CMS will temporarily suspend certain Medicare enrollment screening requirements including site visits and fingerprinting for non-certified Part B suppliers, physicians and non-physician practitioners. In addition, CMS will allow licensed providers to render services outside their state of enrollment. CMS will also establish a toll-free hotline for providers to enroll and receive temporary Medicare billing privileges.
Flexibility and Relief for State Medicaid Agencies. The national emergency declaration also enables CMS to grant state and territorial Medicaid agencies a wider range of flexibilities under section 1135 waivers. States and territories are now encouraged to assess their needs and request these available flexibilities, which are outlined in the Medicaid and CHIP Disaster Response Toolkit. Examples of flexibilities available to states under section 1135 waivers include the ability to permit out-of-state providers to render services, temporarily suspend certain provider enrollment and revalidation requirements to promote access to care, allow providers to provide care in alternative settings, waive prior authorization requirements, and temporarily suspend certain pre-admission and annual screenings for nursing home residents. For more information and to access the toolkit, see here.
- Suspension of Enforcement Activities: CMS will temporarily suspend non-emergency survey inspections, allowing providers to focus on the most current serious health and safety threats, like infectious diseases and abuse. CMS also has announced the temporary suspension of non-emergency survey inspections, allowing providers to focus on the most current serious health and safety threats, like infectious diseases and abuse. As part of this relief, for instance, CMS has suspended nonemergency site inspections at nursing homes and other facilities. See Press Release.
- Other Resources. CMS Central Office and the Regional Offices hosted two webinars in 2018 regarding Emergency Preparedness (EP) requirements and provider expectations. One was an all-provider training on June 19, 2018 (over 3,000 providers participated) and the other an all-surveyor training on August 14, 2018. Both presentations covered the EP Final Rule, which included emergency power supply; 1135 waiver process, best practices and lessons learned from past disasters, helpful resources and more. Both webinars are available here.
CMS also compiled a list of Frequently Asked Questions (FAQs) and useful national emergency preparedness resources to assist state survey agencies (SAs), their state, tribal, regional, and local emergency management partners, and healthcare providers to develop effective and robust emergency plans and toolkits to assure compliance with the EP rules. For additional information see the Survey & Certification Group Emergency Preparedness Regulation dated November 2016, Revised June 1, 2017 and associated Emergency Preparedness Checklists.
CMS and other agencies continue to tailor their response to the COVID-19 outbreak. To keep up with the important work the Task Force is doing in response to COVID-19, see www.coronavirus.gov and for CMS specific information, the Current Emergencies Website.
We hope this update is helpful. For more information about the these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.
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About the Author
Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for 30+ years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications. As a significant part of her work, Ms. Stamer has worked extensively on pandemic, business and other crisis planning, preparedness and response for more than 30 years.
Scribe for the ABA JCEB Annual Agency Meeting with OCR, Vice Chair of the ABA International Section Life Sciences Committee, past Chair of the ABA Health Law Section Managed Care & Insurance Interest Group and the ABA RPTE Employee Benefits & Other Compensation Group, Ms. Stamer is most widely recognized for her decades of pragmatic, leading edge work, scholarship and thought leadership on health and other privacy and data security and other health industry legal, public policy and operational concerns. Ms. Stamer’s work throughout her 30 plus year career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns. As a part of this work, she has continuously and extensively worked with domestic and international health plans, their sponsors, fiduciaries, administrators, and insurers; managed care and insurance organizations; hospitals, health care systems, clinics, skilled nursing, long term care, rehabilitation and other health care providers and facilities; medical staff, accreditation, peer review and quality committees and organizations; billing, utilization management, management services organizations, group purchasing organizations; pharmaceutical, pharmacy, and prescription benefit management and organizations; consultants; investors; EHR, claims, payroll and other technology, billing and reimbursement and other services and product vendors; products and solutions consultants and developers; investors; managed care organizations, self-insured health and other employee benefit plans, their sponsors, fiduciaries, administrators and service providers, insurers and other payers, health industry advocacy and other service providers and groups and other health and managed care industry clients as well as federal and state legislative, regulatory, investigatory and enforcement bodies and agencies.
This involvement encompasses helping health care systems and organizations, group and individual health care providers, health plans and insurers, health IT, life sciences and other health industry clients prevent, investigate, manage and resolve sexual assault, abuse, harassment and other organizational, provider and employee misconduct and other performance and behavior; manage Section 1557, Civil Rights Act and other discrimination and accommodation, and other regulatory, contractual and other compliance; vendors and suppliers; contracting and other terms of participation, medical billing, reimbursement, claims administration and coordination, Medicare, Medicaid, CHIP, Medicare/Medicaid Advantage, ERISA and other payers and other provider-payer relations, contracting, compliance and enforcement; Form 990 and other nonprofit and tax-exemption; fundraising, investors, joint venture, and other business partners; quality and other performance measurement, management, discipline and reporting; physician and other workforce recruiting, performance management, peer review and other investigations and discipline, wage and hour, payroll, gain-sharing and other pay-for performance and other compensation, training, outsourcing and other human resources and workforce matters; board, medical staff and other governance; strategic planning, process and quality improvement; meaningful use, EHR, HIPAA and other technology, data security and breach and other health IT and data; STARK, ant kickback, insurance, and other fraud prevention, investigation, defense and enforcement; audits, investigations, and enforcement actions; trade secrets and other intellectual property; crisis preparedness and response; internal, government and third-party licensure, credentialing, accreditation, HCQIA and other peer review and quality reporting, audits, investigations, enforcement and defense; patient relations and care; internal controls and regulatory compliance; payer-provider, provider-provider, vendor, patient, governmental and community relations; facilities, practice, products and other sales, mergers, acquisitions and other business and commercial transactions; government procurement and contracting; grants; tax-exemption and not-for-profit; privacy and data security; training; risk and change management; regulatory affairs and public policy; process, product and service improvement, development and innovation, and other legal and operational compliance and risk management, government and regulatory affairs and operations concerns. to establish, administer and defend workforce and staffing, quality, and other compliance, risk management and operational practices, policies and actions; comply with requirements; investigate and respond to Board of Medicine, Health, Nursing, Pharmacy, Chiropractic, and other licensing agencies, Department of Aging & Disability, FDA, Drug Enforcement Agency, OCR Privacy and Civil Rights, Department of Labor, IRS, HHS, DOD, FTC, SEC, CDC and other public health, Department of Justice and state attorneys’ general and other federal and state agencies; JCHO and other accreditation and quality organizations; private litigation and other federal and state health care industry actions: regulatory and public policy advocacy; training and discipline; enforcement; and other strategic and operational concerns.
Author of “Privacy and the Pandemic Workshop” for the Association of State and Territorial Health Plans, “From Flu Season to Ebola: Challenges & Best Practices For Containing & Responding To Contagious Diseases for Health Care Organizations,” as well as a multitude of other health industry matters, workforce and health care change and crisis management and other highly regarded publications and presentations, the American Bar Association (ABA) International Section Life Sciences Committee Vice Chair, a Scribe for the ABA Joint Committee on Employee Benefits (JCEB) Annual OCR Agency Meeting and a former Council Representative, Past Chair of the ABA Managed Care & Insurance Interest Group, former Vice President and Executive Director of the North Texas Health Care Compliance Professionals Association, past Board President of Richardson Development Center (now Warren Center) for Children Early Childhood Intervention Agency, past North Texas United Way Long Range Planning Committee Member, and past Board Member and Compliance Chair of the National Kidney Foundation of North Texas, and a Fellow in the American College of Employee Benefit Counsel, the American Bar Foundation and the Texas Bar Foundation, Ms. Stamer also shares her extensive publications and thought leadership as well as leadership involvement in a broad range of other professional and civic organizations. For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.
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